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Opioid

Methadone for Mechanical Ventilation (IMPACTOR Trial)

Phase 4

Waitlist Available

Led By Pascal Kingah, MD,MPH

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients on Intermittent mandatory ventilation (IMV) for more than 72 hours

Patients infused Fentanyl or Hydromorphone for more than 72 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of hospital stay ( upto about 7 days after admission )

Awards & highlights

IMPACTOR Trial Summary

This trial studies the effects of methadone on critically ill patients receiving long-term mechanical ventilation to determine safety and hospital length of stay.

Who is the study for?

This trial is for critically ill patients who've been on mechanical ventilation and opioid pain meds like Fentanyl or Hydromorphone for over 72 hours, are stable, and have had unsuccessful breathing trials. It's not for those with a history of opioid abuse, chronic narcotic use, certain heart or liver conditions, neuromuscular diseases, or without feeding tubes.Check my eligibility

What is being tested?

The study tests if methadone can reduce the time critically ill patients need mechanical ventilation. Participants will either receive usual care or be given methadone. The main focus is to compare ventilator-free days from enrollment to discharge and assess safety and hospital stay length.See study design

What are the potential side effects?

While specific side effects aren't listed here, methadone can generally cause drowsiness, light-headedness, respiratory issues when starting treatment or increasing dosage; it may also affect heart rhythm which will be closely monitored.

IMPACTOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a breathing machine for more than 3 days.

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I have been given Fentanyl or Hydromorphone for over 72 hours.

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I have tried and failed to breathe on my own without assistance.

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My breathing has improved, with stable oxygen levels and minimal support needed.

IMPACTOR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of discharge from icu( upto about 3 days after admission )

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of discharge from icu( upto about 3 days after admission )

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of discharge from icu( upto about 3 days after admission ) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants on methadone that get extubated

Secondary outcome measures

ICU length of stay

ICU mortality

Number of participants that develop prolonged corrected QT interval (QTC) after administration of methadone

+2 more

IMPACTOR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Methadone groupExperimental Treatment1 Intervention

Group II: Non-Methadone groupActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

906 Previous Clinical Trials

323,034 Total Patients Enrolled

Pascal Kingah, MD,MPHPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety measures have been implemented for patients receiving Methadone treatment?

"Due to being a Phase 4 trial, which is indicative of an approved treatment, Methadone's safety has been rated 3 by the Power team."

Answered by AI

Is this research project still recruiting participants?

"The clinical trial in question, which was put up on November 15th 2023 and last updated October 25th 2023 is not recruiting patients at this time. However, 1 alternative research initiative does have active openings for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids

Pascal Kingah 2023. "Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110546.